Toray Industries, Inc., announced today that it and 3SBio Inc. jointly lodged a new drug application for TRK-820 (see note 1) with China’s National Medical Products Administration on November 24. Toray exclusively licensed the orally disintegrating tablets formulation of that proprietary antipruritic drug to 3SBio, a Chinese integrated biotechnology company, in December 2017. TRK-820 is the Toray development code for that medicine, whose international nonproprietary name (INN) is nalfurafine.
The licensing agreement grants 3SBio the exclusively right to develop and market this tablet formulation in China (excluding in Hong Kong, Macao, and Taiwan). 3SBio has conducted clinical development in China. The drug approval application filing was based on results of a placebo-controlled, randomized, double-blind, multicenter bridging study (see note 2) in China. The bridging study assessed the efficacy of TRK-820 in improving pruritus in hemodialysis patients whose ailment responds inadequately to existing therapies. In July this year, the study confirmed that efficacy results were consistent with those in Japan. It identified no new safety concerns for TRK-820.
Pruritus in hemodialysis patients is a generalized, intense itch without inflammation. Histamine commonly causes itching among people but is less of a factor in such cases Antihistamines and other regular treatments for itching thus may not offer sufficient efficacy.
The number of patients with end-stage kidney disease is rising around 12% annually in China, fueling a great need for hemodialysis treatment. The Dialysis Outcomes and Practice Patterns Study (see note 3), which evaluated hemodialysis practices based on samples in more than 20 countries, found that moderate or severe pruritus afflicted 39% of Chinese dialysis patients. The pruritus reduced quality of life from itching and led to anxiety, depression, and sleep disorders in some individuals. China has nothing to offer hemodialysis patients for whom existing pruritus therapies provide no relief. Toray and 3SBio hope that TRK-820 can contribute to dialysis treatment progress in China and help enhance the quality of life for patients there.
Contributing to better medical care and hygiene for people worldwide is one of the four priorities of the Toray Group Sustainability Vision. Toray will continue to leverage advanced materials and innovative technologies to develop high-value-added pharmaceuticals in keeping with its corporate philosophy of contributing to society by creating new value while attaining sustainable growth.
Title : Application for Class 5.1 imported drug approval
Application Receipt Number : JXHS2101099国
Indication : Improving pruritus in hemodialysis patients (use only when sufficient efficacy is not obtained with the existing therapies or treatments)
This agent debuted in Japan in 2009 as in a soft capsule formulation named REMITCH* Capsules 2.5μg to improve pruritus in hemodialysis patients (use only when sufficient efficacy is not obtained with the existing therapies or treatments). The marketing authorization holder is Toray, with Torii Pharmaceutical Co., Ltd., distributing it through a tie-up with Japan Tobacco Inc. Toray domestically launched an orally disintegrating tablets version of TRK-820 in 2017. This tablet can be taken with or without water, making it convenient for people finding it hard to swallow or needing to limit their fluid intake. The tablet can also encourage more people to take medication as directed.
*Toray developed REMITCHTM as the world’s first highly selective kappa opioid receptor agonist. Torii Pharmaceutical distributes this agent in Japan to improve pruritus in dialysis patients and patients with chronic liver disease (use only when sufficient efficacy is not obtained with the existing therapies or treatments).
2. Placebo-controlled, randomized, double-blind, multicenter bridging study
A placebo-controlled trial allocates clinical trial subjects to a control group receiving placebos and a treatment group.
A randomized trial is a study that randomly divides the subject population into multiple groups to compare drug efficacies.
In double-blind studies, neither physicians nor patients know group assignments.
A multicenter study entails amassing clinical trial cases at multiple sites.
A bridging study confirms that overseas clinical trial results are replicable in domestic patients.
3. The Dialysis Outcomes and Practice Patterns Study draws on observational data for dialysis patients around the world in a drive to help improve patient treatment and outcomes. See the following website for details: https://www.dopps.org/OurStudies/HemodialysisDOPPS.aspx